The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

MERCY HOSPITAL JEFFERSON 1400 US HIGHWAY 61 FESTUS, MO 63028 July 30, 2015
VIOLATION: QAPI Tag No: A0263
Based on observation, interview, record review and policy review, the facility failed to have systemic practices in place for the Quality Assessment Performance Improvement (QAPI) Program to reduce medical errors after the facility identified a medication error that resulted in a toxic overdose to one patient (refer to A-286), and failed to provide evidence that the quality indicator data was collected and compared for measurable improvement for improved health outcomes (refer to A-0273).

The severity and cumulative effect of these deficient practices resulted in the facility's non-compliance with the requirements found at Condition of Participation: Quality Assessment and Performance Improvement Program. The facility census was 149.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on interview, record review and policy review, the facility failed to ensure the Quality Assessment Performance Improvement (QAPI) Program consistently reported, measured, analyzed, and monitored for safety one quality indicator (medication errors) of three quality indicators reviewed. The facility failed to monitor the effectiveness and safety of the medication administration program, which had the potential to negatively affect all patients.

The facility census was 149.

Findings included:

1. Even though requested, the facility failed to provide a policy related to medication error data collection, analysis, or related patient safety interventions.

2. Record review of the facility policy titled, "Event Report, Confidential Event Report," dated 07/15/15, showed:
- Reporting of both actual events as well as the near miss is important in our effort to improve patient safety and effectively manage events.
- The event report system is an electronic reporting system that allows co-workers and physicians to easily and quickly report both actual events and near misses.
- An event is defined as any occurrence inconsistent with the normal or usual course for a patient, visitor of operation of the facility/department.
- An actual event reached the patient and may have resulted in actual harm or the potential for harm.
- A medication event is any event that may cause or lead to inappropriate medication which is in the control of the healthcare professional, patient or consumer.
- Events may include prescribing, order communication, dispensing, administration, monitoring and use.
- Each event report is promptly reviewed by the assigned event manager for appropriate management and follow-up.
- Event managers will identify patterns and trends to identify process improvement opportunities in an effort to enhance patient safety.

3. Record review of facility Medication Event totals showed there were:
- Seven medication events in 07/2014;
- 10 medication events in 08/2014;
- 27 medication events in 09/2014;
- 93 medication events in 10/2014;
- 74 medication events in 11/2014;
- 61 medication events in 12/2014;
- 22 medication events in 01/2015;
- 40 medication events in 02/2015;
- 58 medication events in 03/2015;
- 50 medication events in 04/2015;
- 55 medication events in 05/2015; and
- 33 medication events in 06/2015.

4. During an interview on 07/30/15 at 9:10 AM, Staff VV, Director of Pharmacy, stated:
- A medication event was found by pharmacy, after eight vials of Solumedrol (anti-inflammatory steroid) 125 milligrams (mg, unit of measure) each, were intravenously (IV, in the vein) pushed (directly injected), which should have been administered through IV infusion (slower, diluted administration).
- The facility didn't have a procedure for high dose IV push administration of Solumedrol.
- The medication error was not reported through the facility's event report system by the pharmacy, because the patient was not harmed.
- There was confusion throughout the facility as to what a reportable medication error was, and because of the confusion, Staff VV did not know if the numbers of medication errors pulled from the event report system were an accurate reflection of the facility's overall medication errors.
- Medication errors were not measured or analyzed because the facility changed computer programs in 04/2014.
- The facility was unable to quantify the medication errors, and therefore unable to analyze the data. "We have the numbers, but that's about all".
- The variances in the "Medication Event" (medication errors) totals, specifically from 09/14 to 10/14, was when the hospital recognized staff weren't reporting medication errors, and education was provided to staff.
- The decrease in medication event totals since 10/2014, was because the education provided about the medication error reporting was no longer in the forefront of staff minds.

During an interview on 07/30/15 at approximately 11:30 AM, Staff P, Interim Quality Director, verified that the facility had no way to measure or analyze medication errors since the facility changed computer programs in 04/2014. Staff P added that because the facility could not analyze the data, they could not provide facility implemented interventions related to the data.

During an interview on 07/30/15 at 3:58 PM, Staff RR, Chief Executive Officer, stated that he attended Quality Assurance meetings, but was unaware that medication errors were unable to be measured or analyzed.
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, record review and policy review, the facility failed to ensure an ongoing Quality Assurance and Performance Improvement (QAPI) Program was implemented to reduce medical errors when the facility identified a medical error (medication error) that resulted in harm (toxic overdose) to one patient (#30), of one medical error reviewed that resulted in patient harm. This had the potential to affect the safety of all patients when the facility failed to fully investigate the process failures, bring awareness and education to patient care staff, and implement preventative measures to ensure the medical error did not reoccur. The facility census was 149.

Findings included:

1. Record review of the facility policy titled, "Medication Reconciliation," dated 04/2015, showed:
- The development of an accurate home medication list is essential for the safe and appropriate care of the patient.
- At the point of admission, a home medication list is to be obtained in collaboration with the patient and family.
- At admission, each medication listed is to be reviewed with the attending physician who will provide direction on which medications are to be continued, held, or discontinued.
- Medication Reconciliation Technicians (Pharmacy Technicians) are to review and correct the "Prior to Admission" (PTA, facility generated list of medications, also known as medication reconciliation, based on lists or information provided to the facility at the time of admission, that the patient takes as part of their home based medications) medication list, document changes in a progress note, and forward the information to the pharmacist as soon as possible.
- Pharmacists are to review the progress note, PTA medication list, cross reference the documentation for verification, contact the ordering physician for order clarification, and make the necessary changes to the physician's order.

2. Record review of Patient #30's History and Physical (H&P) showed that the patient was admitted [DATE] with a diagnosis of urinary tract infection (UTI) and Rhabdomyolysis (breakdown of muscle tissue, that releases muscle fiber contents into the blood). The H&P, which included the PTA list of medications, showed that the patient's current medications included phenytoin (brand name Dilantin, medication used to treat seizure disorders) sodium extended release 400 milligrams (mg, unit of measure), by mouth (PO), three times a day (TID).

3. Record review of Patient #30's nursing home medication list showed that the patient's medications included Dilantin 400 mg, by oral route (PO) at bedtime (HS). (This did not correlate with phenytoin dose frequency listed on the patient's PTA list).

4. Record review of Patient #30's medication administration record, showed that the patient received phenytoin, or the equivalent drug, at a rate that exceeded the patient's standard dose for nine consecutive days, or a total of 21 doses.

5. Record review of Patient #30's "phenytoin total" laboratory results showed:
- On 02/22/15, 8.6 (therapeutic is 10-20, toxic greater than 30);
- On 03/02/15, 33.6;
- On 03/03/15, 37.8;
- On 03/04/15, 36.9; and
- On 03/05/15, 28.5.
On 03/04/15, the patient's "phenytoin free" laboratory results were "5.4 (Panic)", with greater than or equal to 2.5 considered toxic.

6. Record review of Patient #30's Discharge Summary showed that the patient expired on [DATE], with "Dilantin Toxicity" (overdose) listed as one of the patient's diagnoses.

7. Record review of the facility policy titled, "Serious Reportable Adverse Events," dated 06/2013, showed the policy was to:
- Ensure that the process for identifying, reporting and investigating serious events are standardized, defined and executed according to federal and state regulations.
- Ensure the undesirable patterns or trends in performance and serious events are intensively analyzed so improvement measure are developed and implemented, so as to reduce the probability of future occurrence.
- Educate the hospital's workforce about prevention or improvement strategies necessary to reduce the likelihood for error.
The policy further showed:
- Serious Adverse Reportable Events included patient death or serious injury associated with a medication error.
- Serious event root cause analysis (investigation of the events and causes leading up to an event) are conducted, including front line staff participation, which is key in affecting patient safety improvement activities.
- Department leaders and front line staff are asked/encouraged to participate in the root cause analysis.
- The Chief Nursing Officer or her designee participates in serious event root cause analysis meetings.
- Department leaders and staff complete a root cause analysis report detailing the serious event, causal factors that may have led to the variation in performance, corrective actions taken to reduce the potential for future events, and the evaluation on the success of the corrective actions.
- An action plan is the product of the investigation, and identifies the strategies implemented to reduce the risk of similar events occurring in the future.
- The plan should address responsibility for implementation, oversight, time lines and strategies for measuring the effectiveness of the actions.
- The Director of Quality reports all serious events, investigation analysis, and corrective action plans to the Quality of Care Committee of the health system's governing body.

8. During an interview on 07/28/15 at 1:45 PM, Staff P, Interim Quality Director, stated that a root cause analysis was not conducted on the phenytoin medication error or the events related to Patient #30, because the previous Director of Quality vacated his position.

During an interview on 07/29/15 at 3:00 PM with Staff UU, Clinical Pharmacy Services Manager, and concurrent record review of the pharmacy's investigation of Patient #30's medication error, showed:
- The patient's nursing home medication administration list included phenytoin 400 mg by mouth at bedtime.
- The medication was incorrectly transcribed on 02/22/15 to the Prior to Admission list by Staff WW, Registered Nurse (RN), as phenytoin 400 mg by mouth three times a day.
- Staff ZZ, Physician, ordered the phenytoin 400 mg by mouth three times a day on 02/23/15, as it was incorrectly transcribed on the Prior to Admission list.
- The order was later reviewed by Staff BBB, off-site pharmacist, who overrode a medication dosage warning which stated, "DAILY DOSE 1,200 MG OVERDOSE (MAX 600 MG)", and verified the order (as appropriate).
- The same day, Staff NN, Pharmacy Technician, compared the patient's nursing home medication list to the Prior to Admission list, found four medication transcription errors which included the phenytoin error.
- Staff NN documented the errors and forwarded the documentation, the patient's nursing home medication list and the Prior to Admission list to the facility's pharmacists for review and physician clarification.
- Staff AAA, Pharmacist, reviewed and signed the documentation, but failed to contact the physician for clarification of the medication orders, so the medication orders were not corrected.
- The patient received 18 doses between 02/22/15 and 03/01/15, when the patient's medical status deteriorated, and he was no longer able to swallow medication.
- On 03/01/15, Staff MM, Physician, ordered fosphenytoin (75 mg fosphenytoin is the equivalent of 50 mg phenytoin) 400 mg phenytoin equivalent (PE) IV, every 8 hours (q8). Staff CCC, Pharmacist, received and overrode a medication dosage warning which stated, "DAILY DOSE 1,200 MG PE. OVERDOSE (MAX 480.6 MG PE)", and verified the order (as appropriate).
- The patient received three doses of the fosphenytoin between 03/01/05 and 03/02/15, before it was stopped, after a Dilantin level was checked and resulted as 33.6 (toxic).
- On 03/04/15, the patient arrested (without pulse of respirations) and was resuscitated and transferred to the intensive care unit, where he expired on [DATE].

During an interview on 07/28/15 at approximately 2:00 PM, Staff P, Interim Quality Director, stated that the medication error was caused by problems with computerized physician order entry (CPOE). Staff P stated that the medication order for phenytoin automatically prompted (auto prompt, computerized, pre selected dose or frequency of a medication administration, that defaults when it is ordered, unless manually changed by the person entering the order) the medication to be administered TID, and the dosage warning to prevent the physician from medication overdose orders had been disabled due to decisions made at the facility's corporate level. Staff P verified again that a root cause analysis had not been completed.

9. Observation on 07/29/15 at 10:00 AM with Staff SS, RN, and again on 07/29/15 at approximately 5:10 PM with Staff P, showed during CPOE, the phenytoin orders continued to auto prompt TID administration, and there was no physician warning when phenytoin 400 mg PO TID was ordered.

During an interview on 07/30/15 at 3:00 PM, Staff NN, Pharmacy Technician, stated that she found the error related to Patient #30's phenytoin order the same day the physician ordered the medication (02/23/15). Staff NN stated that she completed the reconciliation changes and documentation according to protocol, and left the documentation for a pharmacist to review. Staff NN added that 85% of all patients require corrections to their medication reconciliation list generated during the admission process, and stated that it "happens daily".

During an interview on 08/05/15 at 9:02 AM, Staff AAA, Pharmacist, stated that she reviewed Patient #30's phenytoin order error after Staff NN documented the needed changes, but could not remember why the order was not corrected.

During an interview on 07/30/15 at 9:10 AM, Staff VV, Director of Pharmacy, stated that the phenytoin auto prompt was never corrected, the alarm was never turned on, and he was not aware of any physician or nursing education related to Patient #30's medication event. Staff VV added that approximately 90% of patients require pharmacy corrections to the PTA list, as generated by the facility.

During an interview on 07/30/15 at 1:05 PM, Staff WW, RN, stated she was never informed that she completed Patient #30's medication reconciliation incorrectly, she never received education related to the medication reconciliation process after Patient #30's admission, and could not remember education related to the medication reconciliation process when staff were trained on the new computer system put into place in 04/2014.

During an interview on 07/30/15 at 3:25 PM, Staff QQ, RN (who was involved in Patient #30's phenytoin administration), stated that he did not know if phenytoin 400 mg PO TID was an excessive dose, but believed it would be "on the high side". Staff QQ stated that he did not receive medication reconciliation process education, or education specific to phenytoin dosages, during or after Patient #30's medication event.

During an interview on 07/30/15 at 3:57 PM, Staff PP, RN (who was involved in Patient #30's phenytoin administration), stated that she believed phenytoin 400 mg PO TID was "more than usual". Staff PP stated that she did not receive education related to medication reconciliation, or to phenytoin specific dosages.

During an interview on 07/30/15 at approximately 9:30 AM, Staff A, CNO, stated that nursing staff did not receive medication reconciliation education related to the phenytoin medication error, because she was unaware that the medication error began with/involved the medication reconciliation process.

During an interview on 08/05/15 at 11:06 AM, Staff ZZ, Physician, stated that he ordered the phenytoin 400 mg PO TID, because it was listed by the nursing staff as a medication that the patient was currently taking. Staff ZZ stated that the dose seemed high, but he trusted the nurses and what they had documented. Staff ZZ stated that he was never informed about the medication error, was never informed that the patient expired, and received no education related to Patient #30's event.

During an interview on 07/30/15 at 2:45 PM, Staff MM, Physician:
- Denied he ordered the fosphenytoin 400 mg PE IV q8 on 03/01/15.
- Stated he requested the pharmacy convert the PO phenytoin dosages to the equivalent of the fosphenytoin dose, so that it could be administered IV (physician order showed that Staff MM gave the telephone order for the fosphenytoin, the order was read back and documented by a RN).
- Stated that he didn't realize the fosphenytoin 400 mg IV q8 was excessive, because Patient #30 had a subtherapeutic Dilantin level on admission (02/22/15).
- Stated that the medication error was brought to his attention, and he and other staff physicians received education related to the phenytoin event, which was provided by Staff XX, Physician.

During an interview on 07/30/15 at 1:15 PM, Staff XX stated there was no education provided to physicians involved in Patient #30 medication error, or to any staff physician that he was aware of. Staff XX stated that he was the physician who determined the patient was Dilantin toxic, based on the patients Dilantin level, and stopped the medication immediately (03/02/15). Staff XX stated that he went to examine the patient on 03/04/15, and found the patient would not respond, was without a pulse and was not breathing, so he called a code (team of medical professionals respond to resuscitate the patient). The patient was transferred to the intensive care unit, and expired the following day.

During an interview on 07/30/15 at 9:10 AM, along with concurrent record review of the Pharmacy and Therapeutics (P&T) Committee Meeting, dated 05/14/15, Staff VV, Director of Pharmacy, stated that the events related to the phenytoin medication error was not discussed during the P&T Committee meeting.

Record review of Board of Directors Meeting Minutes, dated 04/27/15, showed no evidence that the phenytoin medication error was discussed.

During an interview on 07/30/15 at 3:58 PM, Staff RR, Chief Executive Officer, stated that he attended Quality Assurance meetings, but was unaware of the event related to the phenytoin medication error.

During an interview on 07/30/15 at 9:10 AM, Staff UU, Clinical Pharmacy Services Manager, stated that the phenytoin overdose, or events similar to the phenytoin medication event, could occur again due to the current electronic medication reconciliation process.

Medication errors not reported to the Quality Assurance and Performance Improvement Program resulted in no investigation of the process failure, lack of staff education and failure to implement any preventative measures to assist the facility in process improvement for patient safety.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on interview, record review, and policy review the facility failed to ensure nursing staff identified 21 medication errors, which resulted in a toxic overdose to one patient (#30), of one patient reviewed for medication errors, which resulted in patient harm. The facility also failed to educate staff on the medication errors to potentially prevent the reoccurrence of the errors (A0395). These failures had the potential to affect the safety and quality of care for all patients admitted to the facility. The facility census was 149.

The severity and cumulative effects of these systemic failures resulted in the facility being out of compliance with 42 CFR 482.23 Condition of Participation: Nursing Services.

The facility was informed on 08/17/15 that the cumulative effect of these systemic practices had the potential to place all patients at risk for their health and safety, also known as Immediate Jeopardy (IJ).
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on policy review, interview, record review and observation, the facility failed to ensure nursing staff identified medication errors given nine consecutive days, for a total of 21 doses, which resulted in a toxic overdose to one patient (#30), of one patient reviewed for medication errors, which resulted in patient harm. The facility also failed to educate staff on the medication errors to potentially prevent the reoccurrence of the errors. This had the potential to affect the safety of all patients receiving medication. The facility census was 149.

The severity and cumulative effects of this systemic practice had the potential to place all patients at risk for their health and safety, also known as Immediate Jeopardy (IJ).

Findings included:

1. Record review of the facility policy titled, "Medication Reconciliation," dated 04/2015, showed:
- The development of an accurate home medication list is essential for the safe and appropriate care of the patient.
- At the point of admission, a home medication list is to be obtained in collaboration with the patient and family.
- At admission, each medication listed is to be reviewed with the attending physician who will provide direction on which medications are to be continued, held, or discontinued.

2. Record review of Patient #30's History and Physical (H&P) showed that the patient was admitted from a long term care facility on 02/22/15 with a diagnosis of urinary tract infection (UTI) and Rhabdomyolysis (breakdown of muscle tissue, that releases muscle fiber contents into the blood). The H&P showed that the patient's current medications included phenytoin (brand name Dilantin, medication used to treat seizure disorders) sodium extended release 400 milligrams (mg, unit of measure), by mouth (PO), three times a day (TID).

3. Record review of Patient #30's long term care facility medication list showed that the patient's medications included Dilantin 400 mg, by oral route (PO) at bedtime (HS).

4. Record review of the facility medication administration record showed that Patient #30 received phenytoin, or the equivalent drug, at a rate that exceeded the patient's standard dose for nine consecutive days, or a total of 21 doses.

5. Record review of Patient #30's "phenytoin total" laboratory results showed:
- On 02/22/15, 8.6 (therapeutic is 10-20, toxic greater than 30);
- On 03/02/15, 33.6;
- On 03/03/15, 37.8;
- On 03/04/15, 36.9; and
- On 03/05/15, 28.5.
On 03/04/15, the patient's "phenytoin free" laboratory results were "5.4 (Panic)", with greater than or equal to 2.5 considered toxic.

6. Record review of the Discharge Summary showed that Patient #30 expired on [DATE], with "Dilantin Toxicity" (overdose) listed as one of the patient's diagnoses.

During an interview on 07/29/15 at 3:00 PM with Staff UU, Clinical Pharmacy Services Manager, and concurrent record review of the pharmacy's investigation of Patient #30's medication error, showed:
- The patient's long term care facility medication administration list included phenytoin 400 mg by mouth at bedtime.
- The medication was incorrectly transcribed on 02/22/15 to the Prior to Admission (PTA, facility generated list of medications, also know as medication reconciliation, based on medications the patient takes as part of their home based medication routine) list by Staff WW, Registered Nurse (RN), as phenytoin 400 mg by mouth three times a day.
- Staff ZZ, Physician, ordered the phenytoin 400 mg by mouth three times a day on 02/23/15, as it was incorrectly transcribed on the Prior to Admission list.
- The patient received 18 doses between 02/22/15 and 03/01/15, when the patient's medical status deteriorated, and he was no longer able to swallow medication.
- On 03/01/15, Staff MM, Physician, ordered fosphenytoin (75 mg fosphenytoin is the equivalent of 50 mg phenytoin) 400 mg phenytoin equivalent (PE) IV, every 8 hours (q8). Staff CCC, Pharmacist, received and overrode a medication dosage warning which stated, "DAILY DOSE 1,200 MG PE. OVERDOSE (MAX 480.6 MG PE)", and verified the order (as appropriate).
- The patient received three doses of the fosphenytoin between 03/01/05 and 03/02/15, before it was stopped, after a Dilantin level was checked and resulted as 33.6 (toxic).
- On 03/04/15, the patient arrested (without pulse of respirations) and was resuscitated and transferred to the intensive care unit, where he expired on [DATE].

During an interview on 07/28/15 at approximately 2:00 PM, Staff P, Interim Quality Director, stated that the medication error was caused by problems with computerized physician order entry (CPOE). Staff P stated that the medication order for phenytoin automatically prompted (auto prompt, computerized, pre selected dose or frequency of a medication administration, that defaults when it is ordered, unless manually changed by the person entering the order) the medication to be administered TID, and the dosage warning to prevent the physician from medication overdose orders had been disabled due to decisions made at the facility's corporate level. Staff P verified again that a root cause analysis had not been completed.

7. Observation on 07/29/15 at 10:00 AM with Staff SS, RN, and again on 07/29/15 at approximately 5:10 PM with Staff P, showed during CPOE, the phenytoin orders continued to auto prompt TID administration, and there was no physician warning when phenytoin 400 mg PO TID was ordered.

During an interview on 07/30/15 at 9:10 AM, Staff VV, Director of Pharmacy, stated that the phenytoin auto prompt was never corrected, the alarm was never turned on, and he was not aware of any physician or nursing education related to Patient #30's medication event. Staff VV added that approximately 90% of patients require pharmacy corrections to the PTA list, as generated by the facility.

During an interview on 07/30/15 at 1:05 PM, Staff WW, RN, stated she was never informed that she completed Patient #30's medication reconciliation incorrectly, she never received education related to the medication reconciliation process after Patient #30's admission, and could not remember education related to the medication reconciliation process when staff were trained on the new computer system put into place in 04/2014.

During an interview on 07/30/15 at 3:25 PM, Staff QQ, RN (who was involved in Patient #30's phenytoin administration), stated that he did not know if phenytoin 400 mg PO TID was an excessive dose, but believed it would be "on the high side". Staff QQ stated that he did not receive medication reconciliation process education, or education specific to phenytoin dosages, during or after Patient #30's medication event.

During an interview on 07/30/15 at 3:57 PM, Staff PP, RN (who was involved in Patient #30's phenytoin administration), stated that she believed phenytoin 400 mg PO TID was "more than usual". Staff PP stated that she did not receive education related to medication reconciliation, or to phenytoin specific dosages.

During an interview on 07/30/15 at approximately 9:30 AM, Staff A, CNO, stated that nursing staff did not receive medication reconciliation education related to the phenytoin medication error, because she was unaware that the medication error began with/involved the medication reconciliation process.
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on observation, interview, record review and policy review, the facility failed to ensure:
- Adequate oversight by Pharmaceutical Services of medication errors after the facility identified medication errors that resulted in a toxic overdose to one of one patient (#30);
- The pharmacy tracked and reported medication errors that resulted in a toxic overdose for one of one patient (#30) reviewed with medication errors; and
- The pharmacy reported the medication errors to the attending physician and the hospital-wide Quality Assessment and Performance Improvement (QAPI) program.

Please see citation at A0508.

The severity and cumulative effects of these systemic failures had the potential to place all patients at risk of administration of erroneous, inaccurate medication doses and resulted in the facility being out of compliance with 42 CFR 482.25 Condition of Participation: Pharmaceutical Services.

The facility was informed on 08/17/15 that the cumulative effect of these systemic practices had the potential to place all patients at risk for their health and safety, also known as Immediate Jeopardy (IJ).
VIOLATION: REPORTING ADVERSE EVENTS Tag No: A0508
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, record review and policy review, the facility failed to ensure the pharmacy tracked and reported medication errors that resulted in harm (toxic overdose) for one of one patient (#30) reviewed with medication errors. The facility failed to ensure the pharmacy reported the medication errors to the attending physician and the hospital-wide Quality Assessment and Performance Improvement (QAPI) program. This had the potential to affect the safety of all patients when the pharmacy failed to fully investigate the process failures and implement preventative measures to reduce the likelihood for error. The facility census was 149.

The severity and cumulative effects of this systemic practice had the potential to place all patients at risk for their health and safety, also known as Immediate Jeopardy (IJ).

Findings included:

1. Record review of the facility policy titled, "Medication Reconciliation," dated 04/2015, showed:
- The development of an accurate home medication list is essential for the safe and appropriate care of the patient.
- At the point of admission, a home medication list is to be obtained in collaboration with the patient and family.
- At admission, each medication listed is to be reviewed with the attending physician who will provide direction on which medications are to be continued, held, or discontinued.
- Medication Reconciliation Technicians (Pharmacy Technicians) are to review and correct the "Prior to Admission" (PTA, facility generated list of medications, also know as medication reconciliation, based on medications the patient takes as part of their home based medication routine) medication list, document changes in a progress note, and forward the information to the pharmacist as soon as possible.
- Pharmacists are to review the progress note, PTA medication list, cross reference the documentation for verification, contact the ordering physician for order clarification, and make the necessary changes to the physician's order.

2. Record review of Patient #30's History and Physical (H&P) showed that the patient was admitted [DATE] with a diagnosis of urinary tract infection (UTI) and Rhabdomyolysis (breakdown of muscle tissue, that releases muscle fiber contents into the blood). The H&P, which included the PTA list of medications, showed that the patient's current medications included phenytoin (brand name Dilantin, medication used to treat seizure disorders) sodium extended release 400 milligrams (mg, unit of measure), by mouth (PO), three times a day (TID).

3. Record review of Patient #30's long term care facility medication list showed that the patient's medications included Dilantin 400 mg, by oral route (PO) at bedtime (HS). (This did not correlate with phenytoin dose frequency listed on the patient's PTA list).

4. Record review of Patient #30's medication administration record, showed that the patient received phenytoin, or the equivalent drug, at a rate that exceeded the patient's standard dose for nine consecutive days, or a total of 21 doses.

5. Record review of Patient #30's "phenytoin total" laboratory results showed:
- On 02/22/15, 8.6 (therapeutic is 10-20, toxic greater than 30);
- On 03/02/15, 33.6;
- On 03/03/15, 37.8;
- On 03/04/15, 36.9; and
- On 03/05/15, 28.5.
On 03/04/15, the patient's "phenytoin free" laboratory results were "5.4 (Panic)", with greater than or equal to 2.5 considered toxic.

6. Record review of Patient #30's Discharge Summary showed that the patient expired on [DATE], with "Dilantin Toxicity" (overdose) listed as one of the patient's diagnoses.

7. Record review of the facility policy titled, "Serious Reportable Adverse Events," dated 06/2013, showed the policy was to:
- Ensure that the process for identifying, reporting and investigating serious events are standardized, defined and executed according to federal and state regulations.
- Ensure the undesirable patterns or trends in performance and serious events are intensively analyzed so improvement measure are developed and implemented, so as to reduce the probability of future occurrence.
- Educate the hospital's workforce about prevention or improvement strategies necessary
The policy further showed:
- Serious Adverse Reportable Events included patient death or serious injury associated with a medication error.
- Serious event root cause analysis (investigation of the events and causes leading up to an event) are conducted, including front line staff participation, which is key in affecting patient safety improvement activities.
- Department leaders and front line staff are asked/encouraged to participate in the root cause analysis.
- The Chief Nursing Officer or her designee participates in serious event root cause analysis meetings.
- Department leaders and staff complete a root cause analysis report detailing the serious event, causal factors that may have led to the variation in performance, corrective actions taken to reduce the potential for future events, and the evaluation on the success of the corrective actions.
- An action plan is the product of the investigation, and identifies the strategies implemented to reduce the risk of similar events occurring in the future.
- The plan should address responsibility for implementation, oversight, time lines and strategies for measuring the effectiveness of the actions.
- The Director of Quality reports all serious events, investigation analysis, and corrective action plans to the Quality of Care Committee of the health system's governing body.

8. During an interview on 07/28/15 at 1:45 PM, Staff P, Interim Quality Director, stated that a root cause analysis was not conducted on the phenytoin medication error or the events related to Patient #30, because the previous Director of Quality vacated his position.

During an interview on 07/29/15 at 3:00 PM with Staff UU, Clinical Pharmacy Services Manager, and concurrent record review of the pharmacy's investigation of Patient #30's medication errors, showed:
- The patient's long term care facility medication administration list included phenytoin 400 mg by mouth at bedtime.
- The medication was incorrectly transcribed on 02/22/15 to the Prior to Admission list by Staff WW, Registered Nurse (RN), as phenytoin 400 mg by mouth three times a day.
- Staff ZZ, Physician, ordered the phenytoin 400 mg by mouth three times a day on 02/23/15, as it was incorrectly transcribed on the Prior to Admission list.
- The order was later reviewed by Staff BBB, off-site pharmacist, who overrode a medication dosage warning which stated, "DAILY DOSE 1,200 MG OVERDOSE (MAX 600 MG)", and verified the order (as appropriate).
- The same day, Staff NN, Pharmacy Technician, compared the patient's long term care facility medication list to the Prior to Admission list and found four medication transcription errors which included the phenytoin error.
- Staff NN documented the errors and forwarded the documentation, the patient's long term care facility medication list and the Prior to Admission list to the facility's pharmacists for review and physician clarification.
- Staff AAA, Pharmacist, reviewed and signed the documentation, but failed to contact the physician for clarification of the medication orders, so the medication orders were not corrected.
- The patient received 18 doses between 02/22/15 and 03/01/15, when the patient's medical status deteriorated, and he was no longer able to swallow medication.
- On 03/01/15, Staff MM, Physician, ordered fosphenytoin (75 mg fosphenytoin is the equivalent of 50 mg phenytoin) 400 mg phenytoin equivalent (PE) IV, every 8 hours (q8). Staff CCC, Pharmacist, received and overrode a medication dosage warning which stated, "DAILY DOSE 1,200 MG PE. OVERDOSE (MAX 480.6 MG PE)", and verified the order (as appropriate).
- The patient received three doses of the fosphenytoin between 03/01/05 and 03/02/15, before it was stopped, after a Dilantin level was checked and resulted as 33.6 (toxic).
- On 03/04/15, the patient arrested (without pulse of respirations) and was resuscitated and transferred to the intensive care unit, where he expired on [DATE].

During an interview on 07/28/15 at approximately 2:00 PM, Staff P, Interim Quality Director, stated that the medication error was caused by problems with computerized physician order entry (CPOE). Staff P stated that the medication order for phenytoin automatically prompted (auto prompt, computerized, pre selected dose or frequency of a medication administration, that defaults when it is ordered, unless manually changed by the person entering the order) the medication to be administered TID, and the dosage warning to prevent the physician from medication overdose orders had been disabled due to decisions made at the facility's corporate level. Staff P verified again that a root cause analysis had not been completed.

9. Observation on 07/29/15 at 10:00 AM with Staff SS, RN, and again on 07/29/15 at approximately 5:10 PM with Staff P, showed during CPOE, the phenytoin orders continued to auto prompt TID administration, and there was no physician warning when phenytoin 400 mg PO TID was ordered.

During an interview on 07/30/15 at 3:00 PM, Staff NN, Pharmacy Technician, stated that she found the error related to Patient #30's phenytoin order the same day the physician ordered the medication (02/23/15). Staff NN stated that she completed the reconciliation changes and documentation according to protocol, and left the documentation for a pharmacist to review. Staff NN added that 85% of all patients require corrections to their medication reconciliation list generated during the admission process, and stated that it "happens daily".

During an interview on 08/05/15 at 9:02 AM, Staff AAA, Pharmacist, stated that she reviewed Patient #30's phenytoin order error after Staff NN documented the needed changes, but could not remember why the order was not corrected.

During an interview on 07/30/15 at 9:10 AM, Staff VV, Director of Pharmacy, stated that the phenytoin auto prompt was never corrected, the alarm was never turned on, and he was not aware of any physician or nursing education related to Patient #30's medication event. Staff VV added that approximately 90% of patients require pharmacy corrections to the PTA list, as generated by the facility.

During an interview on 07/30/15 at approximately 9:30 AM, Staff A, CNO, stated that nursing staff did not receive medication reconciliation education related to the phenytoin medication error, because she was unaware that the medication error began with/involved the medication reconciliation process.

During an interview on 08/05/15 at 11:06 AM, Staff ZZ, Physician, stated that he ordered the phenytoin 400 mg PO TID, because it was listed by the nursing staff as a medication that the patient was currently taking. Staff ZZ stated that the dose seemed high, but he trusted the nurses and what they had documented. Staff ZZ stated that he was never informed about the medication error, was never informed that the patient expired, and received no education related to Patient #30's event.

During an interview on 07/30/15 at 2:45 PM, Staff MM, Physician:
- Denied he ordered the fosphenytoin 400 mg PE IV q8 on 03/01/15.
- Stated he requested the pharmacy convert the PO phenytoin dosages to the equivalent of the fosphenytoin dose, so that it could be administered IV (physician order showed that Staff MM gave the telephone order for the fosphenytoin, the order was read back and documented by a RN).
- Stated that he didn't realize the fosphenytoin 400 mg IV q8 was excessive, because Patient #30 had a subtherapeutic Dilantin level on admission (02/22/15).
- Stated that the medication error was brought to his attention, and he and other staff physicians received education related to the phenytoin event, which was provided by Staff XX, Physician.

During an interview on 07/30/15 at 1:15 PM, Staff XX stated there was no education provided to physicians involved in Patient #30 medication error, or to any staff physician that he was aware of. Staff XX stated that he was the physician who determined the patient was Dilantin toxic, based on the patients Dilantin level, and stopped the medication immediately (03/02/15). Staff XX stated that he went to examine the patient on 03/04/15, and found the patient would not respond, was without a pulse and was not breathing, so he called a code (team of medical professionals respond to resuscitate the patient). The patient was transferred to the intensive care unit, and expired the following day.

During an interview on 07/30/15 at 9:10 AM, along with concurrent record review of the Pharmacy and Therapeutics (P&T) Committee Meeting, dated 05/14/15, Staff VV, Director of Pharmacy, stated that the events related to the phenytoin medication error was not discussed during the P&T Committee meeting.

Record review of Board of Directors Meeting Minutes, dated 04/27/15, showed no evidence that the phenytoin medication error was discussed.

During an interview on 07/30/15 at 3:58 PM, Staff RR, Chief Executive Officer, stated that he attended Quality Assurance meetings, but was unaware of the event related to the phenytoin medication error.

During an interview on 07/30/15 at 9:10 AM, Staff UU, Clinical Pharmacy Services Manager, stated that the phenytoin overdose, or events similar to the phenytoin medication event, could occur again due to the current electronic medication reconciliation process.

Medication errors not reported to the Quality Assurance and Performance Improvement Program and to the physician, resulted in no investigation of the process failure, lack of staff education and failure to implement any preventative measures to assist the facility in process improvement for patient safety.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, interviews, and policy review the facility staff failed to:
- Perform hand hygiene before applying gloves for two patients #18 and #19 of five patients observed.
- Perform hand hygiene between dirty and clean areas when cleaning an endoscope (a device with a light attached which is used to examine a body cavity) of one observed.
- Perform hand hygiene when entering contact isolation (CI-measures put into place to minimize the possibility of spreading a disease) rooms of two patients (#21 and #22) with Clostridium-difficile (C-diff a highly infectious bacteria which causes diarrhea) of two patients observed.
- Perform hand hygiene between glove changes and between patient care and the environment for one patient (#29) of two patients observed.
- Remove urinals (a container which holds urine) from over-bed tables for three patients (#6, #33 and #34) of three patients observed.
These failed practices of not cleansing hands with soap and water or gel (antiseptic handwash) increased the risk of infection and cross contamination for all patients, visitors and staff. The facility census was 149.

Findings included:

1. Record review of the facility's policy titled, "Hand Hygiene," revised 12/2014, showed directives for staff to perform hand hygiene:
- Before and after having direct contact with patients;
- After removing gloves; and
- After contact with environmental surfaces (including medical equipment) in the immediate vicinity of the patient.

2. Observation on 07/29/15 at 9:40 AM showed Staff R, Registered Nurse (RN), entered the Pre-OP (care provided to a patient before surgical intervention) room of Patient #18 to insert an intravenous catheter (IV through the vein). Without wearing gloves, she applied a tourniquet (a rubber band which is applied to stop blood flow) to the patient's arm and used her index finger to find the vein, swabbed the site with an alcohol pad and then applied gloves without performing hand hygiene. She then inserted the catheter into the vein.

3. Observation on 07/29/15 at 9:55 AM showed Staff R, RN, entered the Pre-OP room of Patient #19 to insert an IV. Without wearing gloves, she then applied a tourniquet to the patients arm and used her index finger to find the vein, swabbed the site with an alcohol pad and applied gloves without performing hand hygiene. She then inserted the catheter into the vein.

During an interview on 07/29/15 at 10:00 AM, Staff R, stated that she should have washed her hands before she applied the gloves since she had touched the patient and contaminated her hands.

4. Observation on 07/29/15 at 10:30 AM showed Staff Y, Licensed Practical Nurse (LPN), cleaned an endoscope and did not perform hand hygiene between glove changes when she moved from the dirty side (to disinfect) to the clean side (to rinse and dry) of the procedure.

During an interview on 07/29/15 at 1:05 PM, Staff T, Infection Control Manager, stated that she would expect that hand hygiene would be performed between any dirty and clean procedure.

5. Observation on 07/29/15 at 2:20 PM showed Staff W, RN, entered the room of Patient #21 who was on CI with a diagnosis of C-diff without performing hand hygiene before she applied gloves.

During an interview on 07/29/15 at 2:25 PM, Staff W, RN, stated that she ordinarily would not use gel before she applied gloves when she entered a room with C-diff because her hands would be wet and then it was hard to get the gloves on. She stated that she also knew that gel didn't kill the spores for C-diff.

6. Observation 07/29/15 at 2:45 PM, showed Staff X, RN, entered the room of Patient #22 who was on CI with a diagnosis of C-diff without performing hand hygiene. She applied gloves, typed on the computer and checked the patient's identification band. She removed her gloves and re-gloved without performing hand hygiene. She then placed medication in a cup and administered the medication to the patient.

During an interview on 07/29/15 at 3:00 PM, Staff X stated that the gel was not effective on C-diff patients. She confirmed that she didn't perform hand hygiene before she applied her gloves.

7. Observation on 07/30/15 at 11:00 AM, showed Staff BBB, RN, entered the room of Patient #29 and performed hand hygiene and gloved. He then administered inhalation medication, listened to lung sounds with his stethoscope, turned the oxygen on and typed on the computer. He did not change gloves and perform hand hygiene between patient care and the environmental surfaces.

During an interview on 07/30/15 at 11:15 AM, Staff BBB, stated that he understood he should have performed hand hygiene between patient care and the environmental surfaces.

8. Record review of the facility's policy titled, "Bedpan and Urinal Use," revised 04/07/14, showed that a urinal should not be placed on the bedside stand or over bed table to prevent the spread of microorganisms (germs that are invisible to the naked eye) from the floor to the patient's bed linens when he uses the device).

9. Observation on 07/28/15 at 1:45 PM of Patient #6's bedside showed an open urinal within six inches of the patient's noon meal tray.

During an interview on 07/28/15 at approximately 1:59 PM, Staff G, Nurse Clinician, stated that staff should have removed the urinal from the patient's over bed table before he ate his noon meal.

10. Observation on 07/28/15 at 2:25 PM of Patient #33's bedside showed an open urinal that contained urine on a over bed table.

11. Observation on 07/28/15 at 2:25 PM of Patient #34's bedside showed an open urinal that contained urine on an over bed table.

During an interview on 07/28/15 at 2:30 PM, Staff K, Nurse Clinician, stated that it was a challenge to keep the urinals off the over bed tables since many patients put them there, even after the staff had removed them.